Company · US
KARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2026. Name variants (Inc, Corp, punctuation) are merged.
367510(k) clearances (1 in 12 months)
19recalls (0 in 12 months)
14recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 52 |
| HET | Laparoscope, Gynecologic (And Accessories) | 29 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 28 |
| HRX | Arthroscope | 28 |
| FJL | Resectoscope | 17 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 13 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 13 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 13 |
| HIH | Hysteroscope (And Accessories) | 11 |
| GWG | Endoscope, Neurological | 10 |
| HIF | Insufflator, Laparoscopic | 9 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 8 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 7 |
| EOX | Esophagoscope (Flexible Or Rigid) | 6 |
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 6 |
| OWN | Confocal Optical Imaging | 6 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 5 |
| FBO | Cystourethroscope | 5 |
| HIG | Insufflator, Hysteroscopic | 5 |
| LJH | System, Irrigation, Urological | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2026 | K252624 | KARL STORZ Laryngoscopes and Accessories KARL STORZ Endoscopy-America, Inc. | EQN |
| Oct 22, 2024 | K240506 | KARL STORZ Holders Karl Storz Endoscopy America, Inc. | OCV |
| Sep 14, 2023 | K223885 | HOPKINS Telescopes Karl Storz Endoscopy America, Inc. | HIH |
| Jun 23, 2023 | K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36 Karl Storz Endoscopy America, Inc. | GCJ |
| Apr 27, 2023 | K223520 | UNIDRIVE SIII System Karl Storz-Endoscopy-America, Inc. | HIH |
| Mar 30, 2023 | K223923 | HOPKINS Telescopes KARL STORZ Endoscopy-America, Inc. | GCJ |
| Mar 17, 2023 | K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable Karl Storz Endoscopy America, Inc. | FJL |
| Dec 20, 2022 | K221004 | HOPKINS Telescopes Karl Storz Endoscopy America, Inc. | GCJ |
| Nov 10, 2022 | K222504 | H1 Karl Storz Endoscopy America, Inc. | GCJ |
| Jun 23, 2022 | K213194 | HD Mediastinoscope Karl Storz Endoscopy America, Inc. | EWY |
| May 13, 2022 | K221174 | Telepack + Karl Storz Endoscopy America, Inc. | FET |
| Jan 20, 2022 | K212458 | Flexible Video-Uretero-Renoscope SSU System Karl Storz Endoscopy America | FGB |
| Dec 29, 2021 | K212656 | Flexible Intubation Video Endoscope Sterile (FIVE-S) Karl Storz Endoscopy America | EOQ |
| Nov 15, 2021 | K212695 | KARL STORZ ICG Imaging System Karl Storz Endoscopy America | OWN |
| Sep 3, 2021 | K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System Karl Storz Endoscopy America, Inc. | FAJ |
| Jul 6, 2021 | K203198 | KARL STORZ Metal Sterilization Trays Karl Storz Endoscopy America, Inc. | KCT |
| May 11, 2021 | K202272 | HD Mediastinoscope Karl Storz Endoscopy America, Inc. | EWY |
| May 7, 2021 | K203572 | Karl Storz Radel Sterilization Trays Karl Storz Endoscopy America, Inc. | KCT |
| Mar 30, 2021 | K201001 | Modulith SLX-F2 Karl Storz Endoscopy America | LNS |
| Feb 25, 2021 | K201945 | KARL STORZ UDEL Sterilization Trays Karl Storz Endoscopy America, Inc. | KCT |
| Dec 29, 2020 | K200965 | XR-MX/1000 Karl Storz Endoscopy America, Inc. | JAA |
| Dec 17, 2020 | K202925 | KARL STORZ ICG Imaging System Karl Storz Endoscopy_America, Inc. | OWN |
| Nov 20, 2020 | K201526 | TIPCAM1 Rubina Video Endoscope System Karl Storz Endoscopy America | GCJ |
| Oct 29, 2020 | K202957 | Flexible Video Cysto-Urethroscope (C-view) KARL STORZ Endoscopy-America, Inc. | FAJ |
| Oct 22, 2020 | K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece KARL STORZ Endoscopy-America, Inc. | ERL |
| Sep 1, 2020 | K201135 | Image1 S CCU, Image1 S 4U Camera Head KARL STORZ Endoscopy-America, Inc. | FET |
| Aug 17, 2020 | K201399 | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 4 Karl Storz-Endoscopy-America, Inc. | OWN |
| Aug 11, 2020 | K200740 | HD Video Rhino Laryngoscope KARL STORZ Endoscopy-America, Inc. | EOB |
| Jun 23, 2020 | K201096 | CO2mbiLED Karl Storz Endoscopy America, Inc. | FCX |
| Dec 20, 2019 | K193235 | Telepack + Karl Storz Endoscopy America, Inc. | FET |
| Sep 18, 2019 | K191357 | Flexible HD Cysto-Urethroscope System KARL STORZ Endoscopy-America, Inc. | FAJ |
| Apr 23, 2019 | K182723 | Flexible HD Cysto-Urethroscope System KARL STORZ Endoscopy-America, Inc. | FAJ |
| Mar 22, 2019 | K182186 | CMOS Video-Rhino-Laryngoscope System KARL STORZ Endoscopy-America, Inc. | EOB |
| Jan 18, 2019 | K183264 | Flex-THOR scope KARL STORZ Endoscopy-America, Inc. | GCJ |
| Nov 20, 2018 | K182696 | Telepack X LED KARL STORZ Endoscopy-America, Inc. | FET |
| Jul 18, 2018 | K180977 | KARL STORZ New Generation Trocars KARL STORZ Endoscopy-America, Inc. | GCJ |
| Apr 17, 2018 | K180146 | KARL STORZ ICG Imaging System Karl Storz Endoscopy America, Inc. | GWG |
| Feb 2, 2018 | K171402 | KARL STORZ Slim Nasopharyngolaryngoscope KARL STORZ Endoscopy-America, Inc. | EOB |
| Aug 2, 2017 | K171717 | AUTOCON III 400 KARL STORZ Endoscopy-America, Inc. | GEI |
| Jul 7, 2017 | K162992 | Karl Storz UROMAT E.A.S.I. Karl Storz Endoscopy America, Inc. | LJH |
| May 25, 2017 | K171238 | KARL STORZ ICG Imaging System KARL STORZ Endoscopy-America, Inc. | OWN |
| May 16, 2017 | K170462 | KARL STORZ ShuntScope KARL STORZ Endoscopy-America, Inc. | GWG |
| Mar 16, 2017 | K162880 | TIPCAM 1S 3D System Karl Storz Endoscopy America, Inc. | GWG |
| Mar 2, 2017 | K162410 | TIPCAM 1S 3D System Karl Storz Endoscopy America, Inc. | EOB |
| Mar 2, 2017 | K161554 | ENDOFLATOR 40, ENDOFLATOR 50 KARL STORZ Endoscopy-America, Inc. | HIF |
| Jan 26, 2017 | K162882 | KARL STORZ ICG Imaging System KARL STORZ Endoscopy-America, Inc. | OWN |
| Oct 21, 2016 | K161555 | KARL STORZ NAV1 Electromagnetic Navigation System Karl Storz Endoscopy America, Inc. | PGW |
| Sep 17, 2016 | K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System KARL STORZ Endoscopy-America, Inc. | GWG |
| May 31, 2016 | K152583 | KARL STORZ Endoscopic ICG Imaging System KARL STORZ Endoscopy-America, Inc. | OWN |
| Feb 1, 2016 | K160044 | Image1 SPIES System Karl Storz Endoscopy America, Inc. | FET |
Newest 50 of 367.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2013 | Karl Storz Endoscopy America Inc Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1.
" Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, unc Terminated |
ECQ | K832010 K954797 +1 |
| Dec 17, 2013 | Karl Storz Endoscopy America Inc Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2.
" Transoral intubation " Transnasal intubation " Evaluation of Terminated |
CAL | None listed |
| Dec 6, 2013 | Karl Storz Endoscopy America Inc Axillent Debakey Grasping Forceps, Part No. 33821DYD
In general the surgeons use 33821DYD Debakey forceps to grasp tissue. Terminated |
GCJ | K934937 |
| Jul 13, 2013 | Karl Storz Endoscopy America Inc 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex.
The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments Terminated |
GBA | None listed |
| May 11, 2013 | Karl Storz Endoscopy America Inc Loop, Cutting, Angled 22FR (26055G/6).
Resectoscope accessories (ie. electrode, cutting loops and cold knives). Terminated |
FJL | K934647 K983569 |
| May 11, 2013 | Karl Storz Endoscopy America Inc Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6).
Resectoscope accessories (ie. electrode, cutting loops and cold knives). Terminated |
FJL | K934647 K983569 |
| May 11, 2013 | Karl Storz Endoscopy America Inc Knife, Cold, Straight (27068K/6).
Resectoscope accessories (ie. electrode, cutting loops and cold knives). Terminated |
FJL | K934647 K983569 |
| May 11, 2013 | Karl Storz Endoscopy America Inc Loop, Cutting, 24FR (26050G/6).
Resectoscope accessories (ie. electrode, cutting loops and cold knives). Terminated |
FJL | K934647 K983569 |
| May 11, 2013 | Karl Storz Endoscopy America Inc Electrode, VaporCut, 24FR (27050SG/6).
Resectoscope accessories (ie. electrode, cutting loops and cold knives). Terminated |
FJL | K934647 K983569 |
| May 11, 2013 | Karl Storz Endoscopy America Inc Electrode, Roller, Vaporization, 24FR (27050RK/6).
Resectoscope accessories (ie. electrode, cutting loops and cold knives). Terminated |
FJL | K934647 K983569 |
| May 11, 2013 | Karl Storz Endoscopy America Inc Electrode, Barrel Bar, 24FR (27050NX/6).
Resectoscope accessories (ie. electrode, cutting loops and cold knives). Terminated |
FJL | K934647 K983569 |
| May 11, 2013 | Karl Storz Endoscopy America Inc Electrode, Roller Ball, 24FR (27050NK/6).
Resectoscope accessories (ie. electrode, cutting loops and cold knives). Terminated |
FJL | K934647 K983569 |
| May 11, 2013 | Karl Storz Endoscopy America Inc Electrode, Coag, Ball End, 24FR (27050N/6).
Resectoscope accessories (ie. electrode, cutting loops and cold knives). Terminated |
FJL | K934647 K983569 |
| May 11, 2013 | Karl Storz Endoscopy America Inc Electrode, Coag, Pointed, 24FR (27050L/6).
Resectoscope accessories (ie. electrode, cutting loops and cold knives). Terminated |
FJL | K934647 K983569 |
| May 11, 2013 | Karl Storz Endoscopy America Inc Electrode, cutting, 24FR (27050G-.30/6).
Resectoscope accessories (ie. electrode, cutting loops and cold knives). Terminated |
FJL | K934647 K983569 |
| May 11, 2013 | Karl Storz Endoscopy America Inc Electrode, cutting, 24FR (27050G/6).
Resectoscope accessories (ie. electrode, cutting loops and cold knives). Terminated |
FJL | K934647 K983569 |
| May 8, 2013 | Karl Storz Endoscopy America Inc KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System,
Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads.
Used as an optional accessory to white light cystoscopy when used i Terminated |
OAY | None listed |
| Nov 7, 2007 | Karl Storz Endoscopy America Inc Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT Terminated |
HIG | None listed |
| Apr 19, 2006 | Karl Storz Endoscopy America Inc Storz Documentation Cart with Articulating Arm, Model Number 9601F Terminated |
KOG | None listed |